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Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)

NCT05831228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-03

No results posted yet for this study

Summary

The purpose of this study is to understand how ketogenic food products affect oxygen toxicity in undersea divers. Oxygen toxicity affecting the central nervous system, mainly the brain, is a result of breathing higher than normal oxygen levels at elevated pressures as can be seen in SCUBA diving or inside a hyperbaric (pressure) chamber. This is a condition that may cause a wide variety of symptoms such as: vision disturbances, ear-ringing, nausea, twitching, irritability, dizziness, and potentially loss of consciousness or seizure. Because nutritional ketosis has been used to reduce or eliminate seizures in humans, it may be beneficial to reduce oxygen toxicity as well. The investigators hope this study will provide a help to develop practical and useful methods for improving the safety of undersea Navy divers, warfighters and submariners.

Conditions

  • Oxygen Toxicity

Interventions

DIETARY_SUPPLEMENT

Ketogenic food products

Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

DIETARY_SUPPLEMENT

Control: Placebo

Participants will be given a dietary supplement comparator prior to the hyperbaric oxygen exposure.

Sponsors & Collaborators

Principal Investigators

  • Bruce Derrick, MD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831228 on ClinicalTrials.gov